An interventional study of Memowave emitting sounds and Memowave not emitting sounds in Sleep Disorder, sponsored by BioSerenity. Withdrawn at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by BioSerenity · Not applicable, Interventional, and Other
Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment
24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the RLRI16 test) will be included;
Each patient spends 3 polysomnography nights at hospital: 1 night of habituation without Memowave device and next 2 nights with Memovave.
The device emits sounds to increase slow brain waves but Memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). The attribution of the night is randomized.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
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Exclusion Criteria:
Patients worn Memowave during one night, and the device emits sounds to increase slow brain signals
Device: Memowave emitting sounds
Patients worn Memowave during one night, and the device doesn't emit sounds
Device: Memowave not emitting sounds
Memowave is worn during one night and emits sounds to increase slow brain waves
Memowave is worn during one night and doesn't emit sounds
accuracy of Electroencephalography signals of Memowave
number of slow waves of Memomave divided by number of slow waves of Gold standard should be under 1
Time frame: 3 days
Quality of the sleep
Score of 1 to 4 (where 4 is a good sleep and 1 a very bad sleep)
Time frame: 3 days
efficiency on mnesic consolidation
memory grid .More the score is high, more the efficiency is better
Time frame: 3 days
efficiency on mnesic consolidation
scale WAIS (Weschler Adult Intelligence scale). The score should be more than 100.
Time frame: 3 days
Start is estimated for Oct 2023; primary completion for Dec 2026, 38 months later.
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This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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